• Educational Qualifications:
• Primary: Bachelor Degree in Pharmacy with 5 years of experience.
• Linguistic Abilities: English and Arabic.
• Certification and Licensure: Kuwait Driving License
A Senior Supervisor Regulatory Affairs executes all activities necessary for the registration of new products and line extension indications and ensure the appropriate licensing, marketing and legal compliance of medical products by performing the following duties:
• Ensure company's products and all its registration comply with the Ministry of health regulations.
• Keep abreast of the latest legislations, guidelines affecting the company’s licensing and its business.
• Oversee the process of securing/renewing the licenses by prepare and submit the related files to establish and run the Company.
• Set proper approval time lines that enable to plan the launching of product in the market with coordinate with warehouse and respective business sections.
• Advise Company Owners and Management on Business licensing procedures and regulatory requirements.
• Coordinate with pharmacovigilance on adverse reaction regulations/issue of pharmaceutical principals and follow up on implementation of necessary action.
• Maintain company trademark registration in Ministry of Health (MOH), Central Medical Stores (CMS), Ministry of commerce, Chamber of Commerce and various ministries and institutions in Kuwait.
• Resolve and document complex issues.
• Liaise in preparing presentations to regulatory authorities. Submit license and clinical trials applications to authorities as per the set deadlines.
• Coordinate with regulatory authorities to secure marketing authorization for the new products.
• Liaise with Regulatory authorities on a regular basis to identify and understand storage, labeling and packing requirements of the company procedures.
• Review of validation, development and stability reports to ensure compliance with license details and relevant guidelines and directives.
Apply Online
• Primary: Bachelor Degree in Pharmacy with 5 years of experience.
• Linguistic Abilities: English and Arabic.
• Certification and Licensure: Kuwait Driving License
A Senior Supervisor Regulatory Affairs executes all activities necessary for the registration of new products and line extension indications and ensure the appropriate licensing, marketing and legal compliance of medical products by performing the following duties:
• Ensure company's products and all its registration comply with the Ministry of health regulations.
• Keep abreast of the latest legislations, guidelines affecting the company’s licensing and its business.
• Oversee the process of securing/renewing the licenses by prepare and submit the related files to establish and run the Company.
• Set proper approval time lines that enable to plan the launching of product in the market with coordinate with warehouse and respective business sections.
• Advise Company Owners and Management on Business licensing procedures and regulatory requirements.
• Coordinate with pharmacovigilance on adverse reaction regulations/issue of pharmaceutical principals and follow up on implementation of necessary action.
• Maintain company trademark registration in Ministry of Health (MOH), Central Medical Stores (CMS), Ministry of commerce, Chamber of Commerce and various ministries and institutions in Kuwait.
• Resolve and document complex issues.
• Liaise in preparing presentations to regulatory authorities. Submit license and clinical trials applications to authorities as per the set deadlines.
• Coordinate with regulatory authorities to secure marketing authorization for the new products.
• Liaise with Regulatory authorities on a regular basis to identify and understand storage, labeling and packing requirements of the company procedures.
• Review of validation, development and stability reports to ensure compliance with license details and relevant guidelines and directives.
Apply Online
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